Barzolvolimab
Chronic Inducible Urticaria, Cold Urticaria, Symptomatic Dermographism, Cold-Induced Urticaria
Phase III
Recruiting
A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)
Nov 19, 2025
Cdx-622
Mild To Moderate Asthma
Phase I
Not Yet Recruiting
A Study of CDX-622 in Participants With Mild to Moderate Asthma
Sep 26, 2025
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Barzolvolimab
Atopic Dermatitis
Phase II
Recruiting
A Study of Barzolvolimab in Patients With Atopic Dermatitis
Dec 09, 2024
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Normal Saline, Cdx-622
Healthy Participants
Phase I
Recruiting
A Phase I Study of CDX-622
Oct 18, 2024
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Cdx-585
Colorectal Cancer, Fallopian Tube Cancer, Renal Cell Carcinoma, Non-small Cell Lung Cancer, Primary Peritoneal Carcinoma, Ovarian Cancer, Pancreatic Cancer, Gastric Cancer, Esophageal Cancer, Head And Neck Cancer, Cholangiocarcinoma, Other Solid Tumors, Bladder Urothelial Carcinoma, Hepatic Cancer
Phase I
Completed
A Study of CDX-585 in Patients With Advanced Malignancies
Mar 15, 2023
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Barzolvolimab
Eosinophilic Esophagitis
Phase II
Active Not Recruiting
A Study of CDX-0159 in Patients With Eosinophilic Esophagitis
Mar 07, 2023
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Celldex Therapeutics Inc (TCE2) have in its pipeline
TCE2 is currently developing the following drugs: Standard Of Care, Barzolvolimab, Barzolvolimab, Cdx-622. These drug candidates are in various stages of clinical development as the company works toward FDA approval.